In former posts, we discussed the DQ in general, and the analytical instrument PQ.
Now let's collect what we need to perform a thourough Installation Qualification (IQ) of an analytical instrument.
First let me underline: this IQ is different from the supplier's usual unpacking documentation. This is not only about checking every component is there. It is the installation qualification, as a prerequisite of the next qualification steps. What does this mean? You really need to establish your whole system with every components and infrastructure elements, all connected. This is the state when you can start your IQ.
Instrument/system inventory
You want to enumerate all instrument components and their connection, registering their types and serial numbers/ other IDs. This is where you can cross-check all components with the promised Functional specifications. This is the point where you should also check all interface/integration components connected (either to each other, or to other systems, such as LIMS), as well.
Documentation inventory
It's also useful to check if all promised/ordered documentation from the vendor is within your hands:
user manual (and perhaps administration guide)
certificate(s) of instrument components
calibration certificate (if applicable)
certificate of the personnel who will perform installation (and maybe) qualification work on the instrument
any certificate of software (again, if applicable)
Review of operation environment
This part is really on you, you shouldn't push this to your vendor, because this is about your lab. You should check you have everything around your instrument you need.
Let's have some examples:
power outlet
network connection
uninterrupted power supply (UPS)
smoke detector
air supply, gas supply
airconditioning
What else? - Computerized system
If you have a computerized system connected to the instrument, there are 2 more sections of the IQ:
Hardware inventory
This is where you crosscheck all specified hardware elements you need to drive your application. Think about disk capacity, RAM, additional network cards, any special periphery etc.
Software inventory
This is not only about the application's review (however that can be also tricky to cross-check all software and service components, drivers, with their version), but also about the operating system, with its restrictions (e.g., user cannot change system time).
One of the best practices I saw was that a user logs in the operating system and also in the application to make sure everything is configured in the right way.
Final thoughts
Whatever qualification your vendor promises to you, I think it is worth the time to perform this kind of IQ on your own, just to make sure you have everything, and you are ready for a deviation-free OQ.
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